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PDA Technical Reports List - PDA Bookstore

PDA Technical Reports No. TITLE Paper Version ... 20 Report on Survey of Current Industry Gowning Practices 1990 01020 41239 ... 25 Blend Uniformity Analysis: ...

https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf

Date added: October 8, 2012 - Views: 529

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Technical Report No. 15 Revised 2009 Validation of Tangential ...

Technical Report No. 15 (Revised 2009) ISBN: 978-0-939459-25-4 ... to complement PDA Technical Report No ... of scope for this technical report. www.pda.org ...

http://store.pda.org/tableofcontents/tr1509_toc.pdf

Date added: January 14, 2013 - Views: 52

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The Use of Stratified Sampling of Blend and Dosage Units to ...

statistical analysis such as the use of methods described in PDA Technical Report 254 should be applied to assess ... stratified dosage unit testing as described in ...

http://www.pqri.org/pdfs/DTC/Articles/Final_BUWG_Stratfied_Sampling.pdf

Date added: April 11, 2012 - Views: 26

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Evaluation, Validation and Implementation of New ...

pda technical report no.33 evaluation, validation and implementation ... pda technical report no. 13, ... vol. 25, no. 5, ...

http://cdn2.hubspot.net/hub/54227/file-14538112-pdf/docs/tr33.pdf

Date added: November 22, 2013 - Views: 21

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Technical Report No. 48 Moist Heat Sterilizer Systems: Design ...

PDA Technical Report No. 1, Revised 2007, (TR 1) Validation of Moist Heat ... 25 Sterilizer Design • Cycle time and throughput requirements

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-48-moist-heat-sterilizer-systems.pdf?sfvrsn=6

Date added: July 31, 2014 - Views: 6

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Solid Oral Dosage Forms Powder Blending - İKEV - Türkçe ...

– Motion imparted by impeller as in Ribbon Blender ... • Parenteral Drug Association (PDA), Technical Report No. 25, “Blend Uniformity Analysis”, 1997.

http://www.ikev.org/haber/bozzonemay31.pdf

Date added: February 20, 2012 - Views: 31

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A Guide to Blend Uniformity - IVT Network - Expanding FDA and ...

PDA TECHNICAL REPORT NO. 25 In 1997, ... Industry, ANDA's Blend Uniformity Analysis” of 1999, PDA was given the opportunity to comment on the proposed draft ...

http://www.ivtnetwork.com/sites/default/files/BlendUniformity_01.pdf

Date added: July 11, 2013 - Views: 24

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TR-43 Revised: Identification and Classification of ...

Technical Report No. 43 (Revised) ... • In the Spring of 2002 the PDA formed its ... © 2013 Parenteral Drug Association 25 . Technical Report No. 43 ...

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-43-(revised).pdf?sfvrsn=6

Date added: September 5, 2014 - Views: 1

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TECHNICAL REPORT NO . 36 - SDFS Arizona Data Services Program

technical report no. 36 mammals of the quitobaquito management area, organ pipe cactus national monument, arizona by ... 25 . iv figures and tables figures

http://sdfsnet.srnr.arizona.edu/data/techreports/TECHRPT36.pdf

Date added: October 8, 2012 - Views: 26

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PDA Draft Technical Report No. 29 - ..:: Pharmanet ...

PDA Technical Report No. 29 ... 25 Rinse Sampling ... PDA Draft Technical Report No. 29 Author: MADSEN Subject:

http://www.pharmanet.com.br/pdf/tr29-002.pdf

Date added: April 30, 2012 - Views: 367

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Cleaning Verification / Validation of Pharmaceutical ...

Cleaning Verification / Validation of Pharmaceutical Manufacturing ... • PDA Technical Report No. 29, ... Bioburden NMT 25 cfu per 25 cm2 – This level is

http://www.aaps.org/uploadedFiles/Content/Sections_and_Groups/Regional_Discussion_Groups/Southern_California_Pharmaceutical/Announcements/SC%20PDG%20Cleaning%20Verification%2019%20SEP%202013.pdf

Date added: October 30, 2013 - Views: 18

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Qualification of temperature -controlled storage areas

Qualification of temperature-controlled storage areas ... 25 2.6.2 Temperature ... 1 PDA Technical Report No. 39: ...

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-qualification-storage-areas-final-sign-off-a.pdf

Date added: June 5, 2014 - Views: 5

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GRUPO TERRA FARMA, A TRAVÉS DE SUS DIFERENTES FILIALES ...

Testing, Technical Report No. 25 (H082) This report was written to clarify the significant regulatory and ... PDA Technical Report 25, Blend Uniformity Analysis:

http://xa.yimg.com/kq/groups/17006184/206611416/name/LIBROS_PDA.pdf

Date added: March 4, 2015 - Views: 1

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Evaluation of Validation Content Uniformity Test Results ...

relevant reference is the PDA Technical Report No. 25: Blend Uniformity Analysis: Validation and In-Process Test-ing(3). The sampling, testing, and corresponding ac-

http://www.ivtnetwork.com/sites/default/files/ValidationContent_01.pdf

Date added: August 29, 2013 - Views: 1

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Near-Infrared Spectroscopy and Imaging for the Monitoring of ...

PDA technical report No. 25.16 The PDA report No. 25 calls for all samples to be between 90 and 110% of the label claim and for the RSD to be <5%.

http://asrg.contactincontext.org/asrg/pdfs/powder_image.pdf

Date added: November 30, 2013 - Views: 7

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Temperature mapping of storage areas - World Health Organization

1 PDA Technical Report No. 39: ... specified temperature range +15°C to +25°C). A hot spot refers to the highest temperature value(s) ...

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf

Date added: June 8, 2014 - Views: 6

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Strategic Considerations for Implementing of Single-Use ...

Strategic Considerations for Implementing ... Source: PDA Technical Report No. 66, ... 25 DCVMN Annual Meeting, ...

http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdf

Date added: January 7, 2015 - Views: 1

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Are We Setting Limits Correctly? Objections to current methods

Are We Setting Limits Correctly? Webinar: ... 25 Lilly approach and variants Fourman and Mullen paper PDA Technical Report No. 29

http://www.cleaningvalidation.com/risk-mapp-gate/2008%20August%20Webinar%20Limits%206%20per%20page.pdf

Date added: January 24, 2013 - Views: 8

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USP Controlled Room Temperature Range Expansion - ...

temperature (25° or 30°) ... PDA Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products, 2011. 5:

http://www.thermosafe.com/blog/wp-content/uploads/2014/02/S20102.pdf

Date added: June 3, 2014 - Views: 3

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In this issue: p~LAL UPDATE® - Associates of Cape Cod, Inc.

Depyrogenation, PDA Technical Report No.3, PDA, Philadelphia, PA). Three ... 25 0.5 1.5 Time [hr] If recoveries are very variable, a larger number should be tested.

http://www.acciusa.com/pdfs/newsletter/LAL_Vol.11No.5.pdf

Date added: March 14, 2012 - Views: 10

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Libero. New dimensions. The independent PDF Data Logger ...

Feature / Specifications Libero Ti1 Libero Ti1-S ... • +/- 0.5°C for the ranges -35 to -10°C and 25° to 70°C ... PDA Technical Report No 39 ...

http://www.nordealer.com/pdf-032008/Libero%20spec.%20tecniche.pdf

Date added: October 4, 2011 - Views: 7

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Cross-walk between EU Annex 11 and US FDA 211, 820, 11; other ...

820.25 11.10(i) EudraLex, ... PDA, Technical Report No. 32 Auditing of Supplier Providing Computer Products and Services for Regulated Pharmaceutical

http://www.computer-systems-validation.net/images/regulatory_analysis_rev_08-FEB-2014_.pdf

Date added: February 26, 2014 - Views: 10

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Libero. The Overview of the Models. - Bancolini Symbol ...

Features / Models Libero Ti1 Libero Ti1-S Libero Ti1-L ... to 70°C +/- 0.5°C for the ranges -35 to -10°C and 25° to ... with PDA Technical Report No 39

http://www.bancolini.com/interne/brochure/LIBERO_TechSpecs_en.pdf

Date added: May 13, 2013 - Views: 2

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Team LIBERO with internal sensors - Technical Specifications

Team LIBERO with internal sensors - Technical Specifications ... -25°..+70°C 0..100 %RH Accuracy ... conform with PDA Technical Report No 39 ...

http://www.nordealer.com/index.php/prodotti/datalogger/usb-datalogger/item/download/85_55a6991f01ee6b8032526aa61155b824

Date added: August 21, 2013 - Views: 1

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Applying a Knowledge-Based Approach to Pharmaceutical Supply ...

PDA Technical Reports 39, ... <30 °C <25 °C 8 to 25 °C 15 to 25 ... PDA Technical Report No. 53 Guidance for Industry:

http://www.interphex.com/RNA/RNA_Interphex_V2/documents/2012/speaker_presentations/ArmindaMontero.pdf?v=634722785190077147

Date added: March 31, 2014 - Views: 3

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Autoclaves Qualification & Validation - Надлежащая ...

PDA Technical Reports • PDA Technical Report No. 1, ... 25 of 39 Autoclaves ... prolonged sterilisation run of empty autoclave after runs with

http://www.gmpua.com/Equipment/Sterility/Sterilization/QualificationofAutoclaves.pdf

Date added: October 19, 2011 - Views: 143

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Process Validation: Solid Dosage Forms - :: สำนัก ...

results and (5) generating “Validation Report” for each validation batch and “Validation Final Report” for the ... PDA Technical Report # 25

http://drug.fda.moph.go.th/drug/zone_gmp/files/GMP2549_2/Aug2206/P2/PV_SDF_1_FDA.pdf

Date added: September 13, 2012 - Views: 94

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Design of Experiments to Establish Temperature and Humidity ...

to Establish Temperature ... •PDA Technical Report No. 39, Guidance ... • Q2: To how many days at 25 °C and 60% RH is the combined

http://www.mbswonline.com/upload/presentation_5-24-2011-19-20-3.pdf

Date added: October 17, 2012 - Views: 6

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Town of Spencer: Spencer Town Center PDA (#280-3)

Spencer Town Center PDA ... and up to 25 hours of technical assistance may be provided to each ... Technical Assistance Report prepared under the Massachusetts ...

http://www.spencerma.gov/Pages/SpencerMA_Bcomm/Planning/SpencerTownCenterPDAReport.pdf

Date added: March 4, 2015 - Views: 1

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The Parenteral Drug Association presents 2013 PDA Europe ...

The Parenteral Drug Association presents... ... special group rate until 25 January 2013, Code: PDA. ... issues from the updated PDA Technical Report No. 33, ...

http://www.tiselab.com/pdf/2013_Microbio_Brochure.pdf

Date added: November 13, 2013 - Views: 12

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Terminal Sterilization vs. Aseptic Processing

PDA Technical Report #36 : ... minimum dose of ≥25 KGy ? ... Steam sterilization of terminal sterilization the reference

http://forums.pharmacyonesource.com/phos/attachments/phos/pharmacy_ops/1377/1/terminal%20sterilization%20v%20aseptic.pdf

Date added: June 4, 2012 - Views: 96

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LIBERO: Innovation Leader in Cold Chain Monitoring

LIBERO: Innovation Leader ... Release report including raw data ... to PDA Technical Report No 39 -Validation certificate

http://www.elpro.com/uploads/tx_elproproducts/LIBERO_Innovation_Leader_01.pdf

Date added: June 19, 2013 - Views: 1

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A New Vision

are derived from tissues with no detectable infectivity ... ≥ 25 kgy. We carry out strict ... PDA Technical Report No. 36, ...

http://www.biomerieux-usa.com/sites/subsidiary_us/files/doc/media_fill_brochure-1.pdf

Date added: January 28, 2015 - Views: 1

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Case Study: Computer Supplier Evaluation Practices of the ...

the company had needed 25 people at each of its manufacturing sites. ... Audit Audit performed in accordance with PDA Technical Report No. 32

http://www.sei.cmu.edu/reports/03tr011.pdf

Date added: January 31, 2012 - Views: 14

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Report # MATC-UI: 117 Final Report

Performing Organization Report No. 25 -1121 0003 117 9. ... PDA personal digital assistant ... Technical Report DOT HS 811 373.

http://matc.unl.edu/assets/documents/matcfinal/Schwarz_TowardsAutonomousVehicles.pdf

Date added: February 15, 2014 - Views: 3

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PDA Forensic Tools - NIST Computer Security Division ...

PDA FORENSIC TOOLKITS ... and the generated report from the script. 25. ... forensic software; forensic toolkits; PDA; Personal Digital Assistant

http://csrc.nist.gov/publications/nistir/nistir-7100-PDAForensics.pdf

Date added: February 14, 2012 - Views: 40

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Development and validation of a microbial counting method for ...

counting was performed according to the USP 30 and PDA Technical Report No. 33. The method used ... This compendium allows for up to 25% variation in

http://www.revistas.usp.br/bjps/article/viewFile/10916/12684

Date added: March 4, 2015 - Views: 1

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Training to Excellence - Nanyang Polytechnic

in PDA Technical Report No. 1) to basics of good sanitary design. ... 25 May 2014 / 18 August 2014 DATE: 29 - 30 April 2014 LOCATION: Pall Singapore, Centre of

http://www.nyp.edu.sg/pdc/display_file.cfm?file_name=NYP+-+Pall+Training+Brochure+2014.pdf&ff=Y

Date added: April 6, 2014 - Views: 24

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PMF NEWSLETTER - The Microbiology Network | Dedicated to the ...

taminated (PDA Technical Report No. 51). The bio-logical indicators used can be readily enumerated. ... has nearly 25 years of experience in the GMP industry, in-

http://www.microbiologyforum.org/content/file/PMFNews.17.05.1105.pdf

Date added: December 8, 2013 - Views: 2

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Cleaning Validation with TOC - Insatech - forsiden

Cleaning Validation with TOC ... Refer to PDA Technical Report 29 and 49 for further guidance 2. Key points: ... INSA 25 / 14 Summary

http://www.insatech.com/downloads/Cleaning_Validation_Jamie_Thompson_GE_Power___Water.pdf

Date added: April 1, 2014 - Views: 2

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SporeNews MesaLabs - bioTRADING - Ready Prepared Media is our ...

Section 8.1 of PDA Technical Report No. 51 suggests that re-running the cycle ... Technical Report No. 51 Biological Indicators for Gas and Vapor ... 25, 101-121 ...

http://www.biotrading.com/en/download/117

Date added: September 6, 2013 - Views: 1

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A Consensus Rating Method for Small Virus-Retentive Filters ...

C. Sigma A7638 ( 99%, ethanol-precipitated), ... scale™-25 disk units, ... PDA Technical Report 41: Virus Filtration. A 0% 20% 40% 60% 80%

http://www.mrzgroup.umd.edu/pdfs/2008_PDA_virus.pdf

Date added: April 3, 2014 - Views: 1

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Introduction 0.1 micron filter use - ResearchGate - Share and ...

Introduction The use of 0.2 µm ... 0,25 AB C min. Pore Size (µm) Figure 3.: Pore Size comparison of different 0.1 micron labeled filters ... PDA Technical Report 26 ...

http://www.researchgate.net/profile/Maik_Jornitz/publication/236230845_EJPS-0802-Filter_pore_size_vs_validation/links/004635172b34a69f5c000000.pdf

Date added: January 9, 2015 - Views: 1

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Human Factors Guidance for the Use of Handheld Portable and ...

Technical Report This document is ... This report provides human factors guidance for the selection and use of handheld, ... PDA Personal Data Assistant . Title:

http://hf.tc.faa.gov/technotes/dot_faa_ct_05_15.pdf

Date added: February 12, 2012 - Views: 14

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Controlling bioburden within biopharmaceutical manufacturing ...

Controlling bioburden within biopharmaceutical manufacturing processes ... irrdation doss of 25 kGy is desired for microbial control or ... (PDA Technical Report No ...

http://parker.com/literature/Domnick%20Hunter%20Process%20Filtration%20Division/PAFD_literature/Life%20Sciences%20Literature/Controlling%20bioburden%20within%20biopharmaceutical%20manufacturing%20processes.pdf

Date added: August 5, 2014 - Views: 1

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Development of a Personal Digital Assistant-based (PDA) Hot ...

Development of a Personal Digital Assistant-based (PDA) Hot-Mix Asphalt ... in inches 25.4 millimeters mm ... TECHNICAL REPORT DOCUMENTATION PAGE ...

http://docs.trb.org/01003747.pdf

Date added: August 29, 2011 - Views: 10

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Method Transfer for Biotechnological Products — Points to ...

PDA Technical Report No. 57 (2012) - Method Transfer Sections • Gap Analysis, Training, Documentation, Post-transfer data trending ... 25 • Column – System ...

http://www.cbinet.com/sites/default/files/files/Sampathkumar_Method%20Transfer%20for%20Biotechnological%20Products%20%E2%80%94%20Points%20to%20Consider%20for%20UPLC%20Methods.pdf

Date added: January 22, 2014 - Views: 1

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Supplier Assessments Audits - İKEV - Türkçe Web Sitesi

PDA Technical Report 32 1. Quality System 2. Project Management 3. ... Computerized Systems Validation Supplier Assessment 25 Dr. Guenter Generlich After the Audit

http://www.ikev.org/haber/2003valid/10%20Supplier%20Audits.pdf

Date added: March 25, 2012 - Views: 99

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PDA Letter • February 2007 Science & Technology Articles of ...

Science & Technology Articles of Interest to the Microbiologist ... preservatives tested were 0.25% ... PDA Technical Report # 28

http://www.microbiol.org/wp-content/uploads/2010/07/sutton.pda_letter.0702.pdf

Date added: March 9, 2012 - Views: 11